II 

Calendar No. 409 

114TH CONGRESS 

2D SESSION S. 1101 

To amend the Federal Food, Drug, and Cosmetic Act to provide for the 

regulation of patient records and certain decision support software. 

IN THE SENATE OF THE UNITED STATES 

APRIL 27, 2015 

Mr. BENNET (for himself and Mr. HATCH) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

APRIL 4, 2016 

Reported by Mr. ALEXANDER, with an amendment and an amendment to the 

title 

[Strike out all after the enacting clause and insert the part printed in italic] 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

provide for the regulation of patient records and certain 

decision support software. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Medical Electronic 

3 Data Technology Enhancement for Consumers’ Health 

4 Act’’ or the ‘‘MEDTECH Act’’. 

5 SEC. 2. REGULATION OF MEDICAL SOFTWARE. 

6 Section 520 of the Federal Food, Drug, and Cosmetic 

7 Act (21 U.S.C. 360j) is amended by adding at the end 

8 the following: 

9 ‘‘(o) REGULATION OF MEDICAL AND CERTAIN DECI10 SION SUPPORT SOFTWARE.— 

11 ‘‘(1) EXCLUSIONS FROM THE CATEGORY OF DE12 VICES.—The term ‘device’, as defined in section 

13 201(h), shall not include the following: 

14 ‘‘(A) Software that is intended for admin15 istrative and operational support of a health 

16 care facility or the processing and maintenance 

17 of financial records, appointment schedules, 

18 business analytics, communication, information 

19 about patient populations, and laboratory 

20 workflow processes. 

21 ‘‘(B) Software that is intended for the pur22 pose of maintaining or encouraging a healthy 

23 lifestyle and are unrelated to the diagnosis, 

24 cure, mitigation, prevention, or treatment of a 

25 disease or disorder. 


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1 ‘‘(C) Except for software intended to inter2 pret or analyze medical image data for the pur3 pose of diagnosis, cure, mitigation, prevention, 

4 or treatment of a disease or condition, elec5 tronic patient records, to the extent that such 

6 records are intended to transfer, store, convert 

7 formats, or display the equivalent of a paper 

8 medical chart, which may include patient his9 tory records if— 

10 ‘‘(i) such records were created, stored, 

11 transferred, or reviewed by health care 

12 professionals, or by individuals working 

13 under supervision of such professionals; 

14 and 

15 ‘‘(ii) such records are part of health 

16 information technology that is certified 

17 under section 3001(c)(5) of the Public 

18 Health Service Act as being in compliance 

19 with applicable certification criteria adopt20 ed under subtitle A of title XXX of such 

21 Act. 

22 ‘‘(D) Except for software intended to inter23 pret or analyze clinical laboratory test data, 

24 software that is intended to transfer, store, con25 vert formats, or display— 


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1 ‘‘(i) clinical laboratory test report 

2 data, results, or findings prior to analysis 

3 or interpretation by a health care profes4 sional; or 

5 ‘‘(ii) clinical laboratory test report 

6 data, results, or findings, or related patient 

7 education information with respect to such 

8 data, to a patient. 

9 ‘‘(E) Except for a device accessory and 

10 software that is intended to acquire, process, or 

11 analyze a medical image or a signal from an in 

12 vitro diagnostic device or a pattern or signal 

13 from a signal acquisition system, software 

14 that— 

15 ‘‘(i) is intended to display, analyze, or 

16 print medical information about a patient 

17 or other medical information (such as peer18 reviewed clinical studies and clinical prac19 tice guidelines); 

20 ‘‘(ii) is intended to support or provide 

21 recommendations to a health care profes22 sional about prevention, diagnosis, or 

23 treatment; and 

24 ‘‘(iii) enables the health care profes25 sional to independently review the basis for 


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1 each recommendation that the software 

2 presents such that it is not the intent that 

3 the health care professional rely solely on 

4 any specific recommendations or results 

5 provided by such software to make a clin6 ical diagnosis or treatment decision. 

7 ‘‘(2) MULTIPLE FUNCTIONALITY PRODUCTS.— 

8 In the case of a product with multiple functionality 

9 that contains a software function that is excluded 

10 under paragraph (1) from the definition of a device 

11 under section 201(h) and a function that meets the 

12 definition of device under section 201(h), the Sec13 retary shall not regulate the excluded software func14 tion of the product as a device, but the Secretary 

15 may assess such software function for the purpose of 

16 determining the safety and effectiveness of the de17 vice function of the product. 

18 ‘‘(3) RULES OF CONSTRUCTION.—Nothing in 

19 this subsection shall be construed as limiting the au20 thority of the Secretary to— 

21 ‘‘(A) exercise enforcement discretion as to 

22 any device subject to regulation under this Act; 

23 or 

24 ‘‘(B) regulate software devices used in the 

25 manufacture and transfusion of blood and blood 


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1 components to assist in the prevention of dis2 ease in humans.’’. 

3 SEC. 3. QUALITY AND STANDARDS. 

4 The Secretary of Health and Human Services shall 

5 ensure that software described in subparagraphs (C), (D), 

6 and (E) of subsection (o)(1) of section 520 of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 360j) (as 

8 amended by section 3) is consistent with appropriate qual9 ity principles and standards for software development and 

10 validation. 

11 SEC. 4. CLASSIFICATION OF ACCESSORIES. 

12 Subsection 513(b) of the Federal Food, Drug, and 

13 Cosmetic Act (21 U.S.C. 360c(b)) is amended by adding 

14 at the end the following: 

15 ‘‘(9) The Secretary shall classify an accessory 

16 under this section based on the intended use of the 

17 accessory, notwithstanding the classification of any 

18 other device with which such accessory is intended to 

19 be used.’’. 

20 SEC. 5. CONFORMING AMENDMENT. 

21 Section 201(h) of the Federal Food, Drug, and Cos22 metic Act (21 U.S.C. 321(h)) is amended by adding at 

23 the end ‘‘The term ‘device’ does not include medical and 

24 decision support software described in section 520(o).’’. 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Medical Electronic Data 

3 Technology Enhancement for Consumers’ Health Act’’ or 

4 the ‘‘MEDTECH Act’’. 

5 SEC. 2. REGULATION OF MEDICAL SOFTWARE. 

6 (a) IN GENERAL.—Section 520 of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 360j) is amended by 

8 adding at the end the following: 

9 ‘‘(o) REGULATION OF MEDICAL AND CERTAIN DECI10 SIONS SUPPORT SOFTWARE.— 

11 ‘‘(1) REGULATION OF CERTAIN SOFTWARE.—The 

12 term ‘device’, as defined in section 201(h), shall not 

13 include a software function that is intended— 

14 ‘‘(A) for administrative support of a health 

15 care facility, including the processing and main16 tenance of financial records, claims or billing in17 formation, appointment schedules, business ana18 lytics, information about patient populations, 

19 admissions, practice and inventory management, 

20 analysis of historical claims data to predict fu21 ture utilization or cost-effectiveness, determina22 tion of health benefit eligibility, population 

23 health management, and laboratory workflow; 

24 ‘‘(B) for maintaining or encouraging a 

25 healthy lifestyle and is unrelated to the diagVerDate Sep 11 2014 22:18 Apr 04, 2016 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6203 E:\BILLS\S1101.RS S1101

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1 nosis, cure, mitigation, prevention, or treatment 

2 of a disease or condition; 

3 ‘‘(C) to serve as electronic patient records, 

4 including patient-provided information, to the 

5 extent that such records are intended to transfer, 

6 store, convert formats, or display the equivalent 

7 of a paper medical chart, so long as— 

8 ‘‘(i) such records were created, stored, 

9 transferred, or reviewed by health care pro10 fessionals, or by individuals working under 

11 supervision of such professionals; 

12 ‘‘(ii) such records are part of health in13 formation technology that is certified under 

14 section 3001(c)(5) of the Public Health 

15 Service Act as being in compliance with ap16 plicable certification criteria adopted under 

17 subtitle A of title XXX of such Act; and 

18 ‘‘(iii) such function is not intended to 

19 interpret or analyze patient records, includ20 ing medical image data, for the purpose of 

21 the diagnosis, cure, mitigation, prevention, 

22 or treatment of a disease or condition; 

23 ‘‘(D) for transferring, storing, converting 

24 formats, or displaying clinical laboratory test or 

25 other device data and results, findings by a 


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1 health care professional with respect to such data 

2 and results, general information about such find3 ings, and general background information about 

4 such laboratory test or other device, unless such 

5 function is intended to interpret or analyze clin6 ical laboratory test or other device data, results, 

7 and findings; or 

8 ‘‘(E) for the purpose of— 

9 ‘‘(i) displaying, analyzing, or printing 

10 medical information about a patient or 

11 other medical information (such as peer-re12 viewed clinical studies and clinical practice 

13 guidelines); 

14 ‘‘(ii) supporting or providing rec15 ommendations to a health care professional 

16 about prevention, diagnosis, or treatment of 

17 a disease or condition; and 

18 ‘‘(iii) enabling such health care profes19 sional to independently review the basis for 

20 such recommendations that such software 

21 presents so that it is not the intent that 

22 such health care professional rely primarily 

23 on any of such recommendations to make a 

24 clinical diagnosis or treatment decision re25 garding an individual patient; 


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1 unless a function described in subparagraph (E) 

2 is intended to acquire, process, or analyze a 

3 medical image or a signal from an in vitro diag4 nostic device or a pattern or signal from a signal 

5 acquisition system. 

6 ‘‘(2) MULTIPLE FUNCTIONALITY PRODUCTS.—In 

7 the case of a product with multiple functions that 

8 contains— 

9 ‘‘(A) at least one software function that 

10 meets the criteria under paragraph (1) or that 

11 otherwise does not meet the definition of ‘device’ 

12 under section 201(h); and 

13 ‘‘(B) at least one function that does not 

14 meet the criteria under paragraph (1) and that 

15 otherwise meets the definition of a ‘device’ under 

16 section 201(h), 

17 the Secretary shall not regulate the software function 

18 of such product described in subparagraph (A) as a 

19 device. Notwithstanding the preceding sentence, when 

20 assessing the safety and effectiveness of the device 

21 function or functions of such product described in 

22 subparagraph (B), the Secretary may assess the im23 pact that the software function or functions described 

24 in subparagraph (A) have on such device function or 

25 functions. 


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1 ‘‘(3) EXCEPTION.— 

2 ‘‘(A) IN GENERAL.—Notwithstanding para3 graph (1), a software function shall not be ex4 cluded from the definition of ‘device’ under sec5 tion 201(h) if— 

6 ‘‘(i) the Secretary determines that the 

7 software function meets the criteria under 

8 subparagraph (C), (D), or (E) of paragraph 

9 (1); 

10 ‘‘(ii) the Secretary makes a finding 

11 that use of such software function would be 

12 reasonably likely to have serious adverse 

13 health consequences; and 

14 ‘‘(iii) the software function has been 

15 identified in a final order issued by the Sec16 retary under subparagraph (B). 

17 ‘‘(B) PROCEDURES.—Subparagraph (A) 

18 shall apply only if the Secretary— 

19 ‘‘(i) publishes a notification and pro20 posed order in the Federal Register; 

21 ‘‘(ii) includes in such notification the 

22 Secretary’s finding, including the rationale 

23 and identification of the evidence on which 

24 such finding was based, as described in sub25 paragraph (A)(ii); and 


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1 ‘‘(iii) provides for a period of not less 

2 than 30 calendar days for public comments 

3 before issuing a final order or withdrawing 

4 such proposed order. 

5 ‘‘(C) CONSIDERATIONS.—In making a find6 ing under subparagraph (A)(ii) with respect to 

7 a software function, the Secretary shall consider 

8 the following: 

9 ‘‘(i) The likelihood and severity of pa10 tient harm if the software function were to 

11 not perform as intended. 

12 ‘‘(ii) The extent to which the software 

13 function is intended to support the clinical 

14 judgment of a health care professional. 

15 ‘‘(iii) Whether there is a reasonable op16 portunity for a health care professional to 

17 review the basis of the information or treat18 ment recommendation provided by the soft19 ware function. 

20 ‘‘(iv) The intended user and user envi21 ronment, such as whether a health care pro22 fessional will use a software function of a 

23 type described in subparagraph (E) of 

24 paragraph (1). 


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1 ‘‘(4) RULES OF CONSTRUCTION.—Nothing in this 

2 subsection shall be construed as limiting the authority 

3 of the Secretary to— 

4 ‘‘(A) exercise enforcement discretion as to 

5 any device subject to regulation under this Act; 

6 ‘‘(B) regulate software used in the manufac7 ture and transfusion of blood and blood compo8 nents to assist in the prevention of disease in hu9 mans; or 

10 ‘‘(C) regulate software as a device under 

11 this Act if such software meets the criteria in 

12 section 513(a)(1)(C).’’. 

13 (b) REPORT.—The Secretary of Health and Human 

14 Services (referred to in this subsection as the ‘‘Secretary’’), 

15 after consultation with agencies and offices of the Depart16 ment of Health and Human Services involved in health in17 formation technology, shall publish a report, every 2 years 

18 beginning after the date of enactment of this Act, that— 

19 (1) includes input from outside experts, such as 

20 representatives of patients, consumers, health care 

21 providers, startup companies, health plans or other 

22 third-party payers, venture capital investors, infor23 mation technology vendors, health information tech24 nology vendors, small businesses, purchasers, employVerDate Sep 11 2014 22:18 Apr 04, 2016 Jkt 059200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6203 E:\BILLS\S1101.RS S1101

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1 ers, and other stakeholders with relevant expertise, as 

2 determined by the Secretary; 

3 (2) examines information available to the Sec4 retary on any risks and benefits to health associated 

5 with software functions described in section 520(o)(1) 

6 of the Federal Food, Drug, and Cosmetic Act (21 

7 U.S.C. 360j) (as amended by subsection (a) of this 

8 Act); and 

9 (3) summarizes findings regarding the impact of 

10 such software functions on patient safety, including 

11 best practices to promote safety, education, and com12 petency related to such functions. 

13 (c) CLASSIFICATION OF ACCESSORIES.—Subsection 

14 513(b) of the Federal Food, Drug, and Cosmetic Act (21 

15 U.S.C. 360c(b)) is amended by adding at the end the fol16 lowing: 

17 ‘‘(9) The Secretary shall classify an accessory 

18 under this section based on the intended use of the ac19 cessory, notwithstanding the classification of any 

20 other device with which such accessory is intended to 

21 be used.’’. 

22 (d) CONFORMING AMENDMENT.—Section 201(h) of the 

23 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)) 

24 is amended by adding at the end the following: ‘‘The term 


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1 ‘device’ does not include software functions excluded pursu2 ant to section 520(o).’’. 

Amend the title so as to read: ‘‘A bill to amend the 

Federal Food, Drug, and Cosmetic Act to provide for the 

regulation of patient records and certain decision support 

software.’’. 


sradovich on DSK3TPTVN1PROD with BILLS
Calendar No. 409 

114TH CONGRESS 

2D SESSION S. 1101 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

records and certain decision support software. Act to provide for the regulation of patient 

APRIL 4, 2016 

Reported with an amendment and an amendment to the 

title 


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